The authorisation expands the indication for Impella heart pumps to deliver left ventricular unloading therapy for Covid-19 patients


The FDA EUA expands the indication for Impella heart pumps. (Credit: Business Wire.)

Abiomed has received the US Food and Drug Administration (FDA) emergency use authorisation (EUA) for its left-sided Impella heart pumps to support therapy for Covid-19 patients.

Covid-19 causes extensive inflammation that can damage the lungs and heart, and may cause severe left ventricular dysfunction, establishing as pulmonary oedema or myocarditis.

The authorisation expands the use of Impella as an ECMO unloading therapy to include COVID-19 patients with pulmonary edema or myocarditis.

Impella combined with ECMO therapy, dubbed ECpella, is said to help physicians treating Covid-19 patients with both heart and lung failure.

The company said that the current authorisation marks the second FDA EUA for Impella during the Covid-19 pandemic, following the expanded EUA for Impella RP, granted in May 2020.

The expanded indication includes patients with Covid-19-related right ventricular complications, including right ventricular dysfunction related to pulmonary embolism.

University of Pennsylvania lung transplantation and ECMO surgical director Christian Bermudez said: “The early clinical evidence continues to accrue in favor of including left ventricular unloading in many patients on ECMO.

“The superior clinical outcomes from the combination of Impella and ECMO are likely the result of reducing the stress on the myocardium and work required of the left ventricle, also reducing secondary lung injury due to pulmonary congestion.”

Impella heart pump was initially granted FDA approval in 2008

Abiomed said that collectively, the two EUAs will facilitate the use of Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella RP for Covid-19 patients.

The company claimed that Impella is the only cardiovascular therapeutic device to receive FDA EUA to treat Covid-19 patients, and is the smallest heart pump in the world. The device was initially granted FDA approval in 2008 and FDA PMA approval in 2015.

Furthermore, Impella has delivered left ventricular unloading therapy to around 10,000 ECMO patients, in the last 10 years.